EP3247418A1

EP3247418A1 - Gelling product for fluid-collecting container

Info

Publication number: EP3247418A1
Application number: EP16700269.0A
Authority: EP
Inventors: Lukas Bannwart
Original assignee: Medela Holding AG
Current assignee: Medela Holding AG
Priority date: 2015-01-20
Filing date: 2016-01-11
Publication date: 2017-11-29
Also published as: EP3047862A1; WO2016116314A1; CN107206132A; US20180008757A1; JP2018501895A

Abstract

The invention relates to a gelling product for solidifying a body fluid siphoned-off into a liquid collecting container (2, 3, 4) comprising an inner chamber, a gelling agent (14) arranged in the inner chamber and a water-soluble covering (1, 10'). Said water-soluble covering (1, 10') is made of a textile material. As a result, a premature bursting of the gelling product, in particular a gelling bag, is prevented.

Description

TITLE

Gelling product for fluid collection container

TECHNICAL FIELD The present invention relates to a gelling product for solidifying a body fluid aspirated in a fluid collection container.

STATE OF THE ART

For aspirating body fluids or secretions from body cavities or wounds, stationary or mobile suction systems are used in the medical field, in particular in the thorax drainage. These systems each comprise a suction source, for example a vacuum pump or a central vacuum, and one or more drainage tanks. A vacuum line connects the drainage container to the suction source, and a drainage line leads from the drainage container to the patient. The applied vacuum creates a negative pressure in the container, and the liquid to be aspirated or the secretion of the patient to be sucked off is sucked into the drainage container and collected there. The drainage container may be rigid or it may be a soft, flexible bag. If a bag is used, it can again be arranged in a rigid, preferably airtight, sealable outer container.

A container filled with extracted body fluid must be disposed of properly. This is especially the case when blood is sucked out. Thus, during transport and disposal of the container no liquid can escape to the outside and thus to minimize the risk of infection, the liquid is already solidified or thickened in the container to a viscous gel. Gelled fluid containers fall under a different class of disposal than containers with unconsolidated contents. The Disposal is easier and cheaper.

Such gelling granules are known, for example, from US Pat. No. 5,595,731. To prevent the powder or granules from entering narrow areas of the container or even the drainage hoses before use, it is usually additionally packed.

US 5,307,819, US 5,234,419, US 5,185,007, US 5,279,602 and WO 2010/006458 disclose partitions between a gelling agent-containing portion and the remaining interior of a fluid collection container, the partitions being actively removed by the user. However, if the hospital staff forgets to remove the partition, the fluid remains unthickened.

US 6,615,862 discloses a floating ball having a water-soluble film bag disposed therein.

In US 5 238 582 a rigid drainage container is shown in which a bag is suspended with a gelling agent. The outer shell of the bag is either a water-soluble film or a water-permeable fabric or a water-permeable pulp. WO 2009/144486 and WO 2013/030581 disclose a drainage bag in which a small bag or a sachet filled with gelling granules is loosely inserted. The small bag or sachet has a shell of water-soluble paper. In other cases, these gelling bags have an outer shell of a water-soluble film. Gelling products with water-soluble outer shells are inexpensive and can be used everywhere. However, they have the disadvantage that they often burst already before use. Hospitals finding gelled bags bursting at individual new fluid collection containers tend to return the entire batch to the manufacturer.

SUMMARY OF THE INVENTION It is therefore an object of the invention to provide a low-cost gelling product, in which the risk of bursting of the outer shell is minimized.

This object is achieved by a gelling product having the features of patent claim 1. The gelling product according to the invention for solidifying a body fluid extracted in a fluid collecting container has an interior, a gelling agent arranged in the interior and a water-soluble cover. According to the invention, the water-soluble cover consists of a textile material. It has been found that pouches burst more easily when previously exposed to elevated temperature and humidity. This is the case, for example, when the fluid collection container is sterilized with gelled product inserted, e.g. Ethylene oxide (ETO) - sterilized. In this type of sterilization, the gelling product is typically exposed to temperatures of 50 ° C and a humidity of 70%. The gelling or solidifying agent begins to swell. If the outer shell is a water-soluble film, it contracts due to the temperature or the temperature difference. It can be a hard bag. In colder temperatures, especially in winter at minus temperatures or in too cold rooms, the film is brittle and can burst even with a slight blow.

Thanks to the use according to the invention of a textile, water-soluble material for the cover, this can be prevented since the material does not become brittle. If the material has sufficient elasticity, it also prevents the bag from hardening with a slightly swollen gelling agent.

The inventive gelling product can thus be easily sterilized together with the fluid collection container prior to use.

The term "textile material" is used here in the usual sense, that is, it is meant a fabric which has been assembled from fibers and / or threads.The textile material may be, for example, a fleece or felt It may be made of a natural base material, a plastic or a mixture thereof. The term "water-soluble" means that the material dissolves upon contact with water or a liquid containing water in the temperature range of application of the gelling product Preferably, the inventive cover dissolves in cold water or at least in contact with water in the room temperature range In a preferred embodiment, the water-soluble cover consists of PVA (polyvinyl acetate). The water-soluble cover according to the invention preferably consists of a fleece, in particular a PVA fleece However, the other above-mentioned embodiments of textile materials can also be used In one embodiment, the gelling product consists only of the gelling agent and the textile cover mentioned t is a second cover, which consists of a water-soluble and water-impermeable material and which is arranged between the water-soluble textile cover and the gelling agent. Preferably, this second cover consists of a film, in particular of PVAL (polyvinyl alcohol). The second cover may be fixedly connected to the first cover, for example, form a two-layer composite material, or it may be formed self-supporting as an independent element.

The gelling agent is usually a granulate of known type, for example a swellable, water-insoluble crosslinked polymer. However, other types of thickening or solidifying agents may be used.

In a preferred embodiment, the water-soluble cover completely surrounds the gelling agent. Preferably, the cover forms a bag in which the gelling agent is held. This bag may preferably be arranged loosely in or secured in a fluid collection container. The pouch can be stored in stiff F 1 ui dsamme 1 as well as in soft, flexible fluid collection pouches. If the gelling product is designed as a bag, it preferably has at least one closure zone to form a closed cavity, which forms the interior space for receiving the gelling agent. The bag can be formed from a multi-part textile cover. Preferably, however, the cover is one or a maximum of two pieces.

The sealing zone may be designed differently depending on the choice of material and the shape of the gelling product. Preferably, it is a seal that firmly joins two layers of the material of the cover or one layer of the cover to another material. The compound must prevent powdery or granular gelling agent from escaping from the interior at an early stage.

However, the closure zone may alternatively or additionally be a seam, a glued zone or a welded seam.

The gelling bag can have any shape. Flat rectangular or oval shapes with two closure zones in the transverse direction have proven successful. If the gelling bag is made of a one-piece fabric or fleece, it usually has a single closure zone in its longitudinal direction. The frontal closure zones may be formed straight or curved.

In other embodiments, the bag has a round or rectangular cross-section with a closure zone surrounding the entire periphery of the bag and being self-contained. This form can be formed, for example, by laying two approximately identically shaped fabrics or nonwovens on top of each other and sealing them together.

In another embodiment, the bag is formed from a single folded sheet material with a closure zone having two free ends. The side edge of the bag lying between the ends is already closed by the fold itself.

In a further embodiment, the bag is torus-shaped. In another Ausführangsform the bag is bag-shaped and closed with a clip or clip.

The gelling product according to the invention is preferably packed moisture-tight for transport and storage individually or together with identical gelling products, for example in foil bags or in lined cardboard boxes.

The gelling product according to the invention can be formed as a body in which only part of its outer shell is formed by the water-soluble cover and the remaining area is water-insoluble. Its interior can be formed for example by a rigid hollow cylinder, a rear wall and a rear wall spaced front wall, wherein the front wall is formed by the water-soluble cover. Such a gelling product with only partially water-soluble outer shell can be placed or attached as a separate element in a container. However, it may also be a solid and in particular an integral part of a fluid collection container of a drainage device for aspirating a body fluid. The invention therefore further comprises a fluid collection container for receiving an aspirated body fluid, wherein the fluid collection container has a receiving space for receiving the extracted body fluid and such gelling, wherein the water-soluble cover forms a partition between the interior of the gelling product and the receiving space and wherein the rigid hollow cylinder and / or the rear wall is formed integrally with a surrounding the gelling product wall of the fluid collection container.

The invention further comprises a fluid collection container for receiving an aspirated body fluid, wherein the fluid collection container has a receiving space for receiving the extracted body fluid and a gelling product described above, wherein the gelling product is arranged in an in-use position of the fluid collection container lower portion of the receiving space. The gelling product can be a loosely inserted bag or a loosely inserted capsule with one except for the one water-soluble cover be stiff exterior. The gelling product can also be attached to the fluid collection container, in particular it can form part of the wall of the fluid collection container. The erfmdungsgemässe gelling prevents premature bursting of AußenhüUe.

Further embodiments are given in the dependent claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will be described below with reference to the drawings, which are given by way of illustration only and are not to be interpreted as limiting. In the drawings show:

1 shows a rigid drainage fluid collection container with an inserted gelling bag according to the invention;

FIG. 2 shows a drainage fluid collection bag with a flexible bag and a rigid lid and with an inserted gelling bag according to the invention;

FIG. 3 is a perspective view of a gelling bag according to the invention in a first embodiment; Figure 4 is a view of the gelling bag according to Figure 3 from above;

5 shows a partial section through a gelling bag in a second

Embodiment according to the invention; Figure 6 is a view of the gelling bag according to Figure 5 from above;

7 shows a view of a gelling bag according to the invention from above in a third embodiment, a partially sectioned perspective view of a gelling bag according to the invention in a fourth embodiment; a partially sectioned perspective view of a gelling bag according to the invention in a fifth Ausfuhrungsförm; a partially sectioned perspective view of a gelling bag according to the invention in a sixth embodiment; a partially cutaway perspective view of a gelling bag according to the invention in a seventh embodiment; a partially cutaway perspective view of a gelling bag according to the invention in an eighth embodiment; a partially cutaway perspective view of a gelling bag according to the invention in a ninth embodiment; a perspective view of a gelling bag according to the invention in a tenth embodiment; a partially sectioned perspective view of the gelling bag according to Figure 14; a partially sectioned perspective view of a gelling bag according to the invention in an eleventh embodiment; a longitudinal section through a gelling bag according to the invention in a twelfth embodiment;

Figure 18 is a perspective view of a part of a stiff

Fluidsammelbehälters with a novel gelling in one twelfth embodiment;

FIG. 19 shows a longitudinal section through the container part according to FIG. 18; FIG. 20 shows a partial section through the container part according to FIG. 18 and FIG

21 shows a partial section through the gelling product and an adjacent region of the container part according to FIG. 18.

DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 shows a known drainage fluid collection container 2, as used for example together with a chest drainage pump. It is for single use and is usually disposed of together with the pumped body fluids of the patient.

The container 2 is preferably made of a rigid or rigid plastic. It has a drainage connection 20 for connection to a suction line leading to the patient and a suction connection 21 for connection to a vacuum source, for example the drainage pump. Otherwise, the container 2 is preferably sealed.

In the hollow receiving space of the container 2, a gelling product according to the invention, here in the form of a gelling bag 1, is inserted. It is preferably loosely inserted, i. not attached to the container 2.

FIG. 2 shows a drainage bag arrangement 3 of known type. It has a flexible drainage bag 30 made of plastic and a closure lid 31. The drainage bag 30 is fixed and non-destructive connected to the closure lid 31. The closure lid 31 has a drainage connection 310 for connection to a patient-side drainage line and a suction connection (not visible here in the figure) for connection to a suction source. These Drainage bag assembly is usually held in use in a rigid outer container, not shown here, wherein the closure lid 31 rests on the upper edge of the outer container. This drainage bag assembly 3 is disposed of after first filling with body fluid together with this. As can be seen in Figure 2, it also has a loosely inserted and not attached to the drainage bag or on the lid gelling 1.

FIGS. 3 and 4 show a first exemplary embodiment of such a gelling bag 1, as can be used in the containers according to FIGS. 1 and 2. He has a shell or cover of a one- or multi-part water-soluble textile material. The material has closure zones, here sealed areas, so that a closed interior for receiving a known gelling agent, in particular in granular form, is formed. In the embodiment shown here, a one-part nonwoven, for example a PVA nonwoven, is folded twice in the longitudinal direction and sealed in the longitudinal direction. The corresponding seam is provided with the reference numeral 13. At each of the two end faces there is a transversely extending seal 12, with an unsealed edge protruding on both sides. Between the two end seals such a body 10 is formed with the mentioned interior. As can be clearly seen in FIG. 4, the end-side seals 12 extend in a straight line. This gelling bag 1 can be produced and filled relatively easily from a material web or a material hose. Instead of seals can be, as mentioned above, use other types of connections.

The embodiment according to FIGS. 5 and 6 differs from the previous one only in the form of the end-side seals 12. Here they are curved. In Figure 5, the gelling agent is additionally provided with the reference numeral 14.

In the embodiment according to FIG. 7, the end-side seals 12 extend over the entire edge to the respective free end.

The gelling bag 1 according to FIG. 8 has a round cross-section, wherein it is formed like a sphere with flattened poles. Here is a circumferential and self-contained seal 12 is present. The gelling bag 1 according to FIG. 9 corresponds to that of FIG. 8, the seal 12 in this case again extending to the free end of the edge 11. The embodiments according to Figures 10 and 11 are formed by a one-piece cover was folded only once, so that an edge of the gelling bag 1 is formed by the material itself. The sealed seam 12 is therefore not self-contained but has two free ends at this edge. The difference between the two figures 10 and 11 again consists in the width of the seal 12th

In FIGS. 12 and 13, the shape of the cross section of the gelling bag 1 and of the main body 10 is again rectangular with rounded corners. Here, however, the seal 12 is circumferential and self-contained. It may in turn be spaced from the free edges of the edges 11 or extend over the entire width thereof. In these examples, preferably, the cover is in two parts, the two parts being superimposed and connected together. In particular, they can be welded, sewn, sealed or glued together.

In the embodiment according to Examples 14 and 15, the gelling bag 1 is toroidal.

FIG. 16 shows a gelling bag 1, in which the cover is gathered together and held together with a clip or another fastening means. The remaining part of the cover, which does not form the base body 10, is provided with the reference numeral 16 in the figure. A seal or other other connection may or may not be present.

FIG. 17 shows a further variant of a gelling bag according to the invention. The bag is formed by a two-ply material which completely surrounds the gelling agent 14. Outside, it is formed by the textile water-soluble first cover 10 already described above. Inside is a second cover, which is water-soluble, but impermeable to water. Preferably, the second cover 17 is a foil. The first cover 10 in turn preferably consists of a non-woven, preferably from PVA. The water-soluble but water-impermeable second cover 17 is preferably made of a PVAL film. Both covers 10, 17 together form the edge 11. They can be arranged loosely one above the other, ie both be formed as a bag. However, they may also form a common composite material and be formed into a single bag.

FIGS. 18 to 21 show a further gelling product. Here, the cover does not form a complete enclosure of the gelling agent 14. The gelling product has a stiff or rigid body, which is closed on one side by the water-soluble cover 10 '. The body is formed in this example by a hollow cylinder 40 and a rear wall 41. The rear wall 41 opposite end face of the hollow cylinder 40 is covered by the cover 10 '. The rear wall 41 is part of a rigid fluid collection container 4 of a drainage device. Preferably, the gelling product 1 'is arranged in the lower region of the fluid collection container 4.

The fluid collection container 4 otherwise corresponds, for example, the container as shown in the aforementioned WO 2010/006458. In Figures 18 to 20, only one half of the container is shown. The receiving space 42 for the extracted body fluid is thus not shown closed. The counterpart closing the receiving space 42 and the container is not shown, but corresponds to the counterpart according to WO 2010/006458.

As can be seen in FIG. 19, the hollow cylinder 40 is preferably formed in one piece with the rear wall 40 of the container 4. They are preferably made of plastic. However, the hollow cylinder 40 and the cylinder 40 closing part of the rear wall 40 may also be formed as a one-part or multi-part insert and be used fluid-tight in the rest of the rear wall. Furthermore, instead of a cylindrical shape, another shape, for example a rectangular or rectangular shape, can also be selected. The closure zone, here a seal of the cover 10 'on the cylinder 40, is provided with the reference numeral 12'.

As can be clearly seen in Figures 20 and 21, is in the interior of the gelling in turn, the gelling agent 14, in particular in the form of granules arranged. The cover 10 'in this example also has contact with the liquid upon filling the canister with bodily fluids and dissolves accordingly so that the gelling agent 14 is released and the liquid is thickened.

LIST OF REFERENCE NUMBERS

I gelling bag 2 drainage fluid collection container

1 'gelling product 20 drainage connection

10 main body 21 suction connection

10 'cover

I I edge 3 drainage bag assembly

12 first closure zone 30 drainage bag

12 'closure zone 31 closure lid

13 second closure zone 310 drainage connection

14 gelling agent

15 closure clip 4 drainage container

16 remaining part of the cover 40 hollow cylinder

17 second cover 41 rear wall

42 recording room

Claims

A gelling product for solidifying a body fluid sucked in a fluid collecting container (2, 3, 4), the gelling product having an interior space, an interior gelling agent (14) and a water-soluble cover (1, 10 '), characterized in that water-soluble cover (1, 10 ') consists of a textile material.

2. gelling product according to claim 1, wherein the water-soluble cover (10, 10 ') consists of a non-woven.

3. Gelling product according to one of claims 1 or 2, wherein the water-soluble cover (1, 10 ') consists of PVA (polyvinyl acetate).

A gelling product according to any one of claims 1 to 3, wherein there is a second cover (17) made of a water-soluble and water-impermeable material and disposed between the water-soluble textile cover (10) and the gelling agent (14).

5. Gelling product according to one of claims 1 to 4, wherein the water-soluble textile cover (1, 10 ') completely surrounds the gelling agent (14).

6. gelling product according to any one of claims 1 to 5, wherein the water-soluble textile cover is a bag (1).

7. gelling product according to claim 6, wherein the bag (1) has a substantially rectangular shape with two end-side closure zones (12) to form a closed cavity, which forms the interior.

A gelling product according to claim 6, wherein the bag (1) has a round or rectangular cross-section, there being a closure zone (12) which circumscribes and is self-contained throughout the bag periphery, the closure zone (12) forming a closed cavity which the interior forms.

A gelling product according to claim 6, wherein the bag (1) is formed from a single folded sheet material and wherein there is a closure zone (12) having two free ends, the closure zone (12) forming a closed cavity which forms the interior.

10. gelling product according to claim 6, wherein the bag (1) is torus-shaped.

11. gelling product according to claim 6, wherein the bag (1) is bag-shaped and closed with a clip (15) or a clip.

A gelling product according to any one of claims 1 to 5, wherein the interior is formed by a rigid hollow cylinder (40), a rear wall (41) and a front wall spaced from the rear wall (41), the front wall being penetrated by the water-soluble cover (10 '). is formed.

A gelling product according to claim 12, wherein the gelling product is a constituent of a fluid collection container (4) of a drainage device for aspirating a body fluid.

14. Fluid collection container for receiving an extracted body fluid, wherein the fluid collection container (4) has a receiving space (42) for receiving the extracted body fluid and the gelling product according to claim 13, wherein the water-soluble cover (10 ') has a partition wall between the interior of the gelling product and the Receiving space (42) forms and wherein the rigid hollow cylinder (40) and / or the rear wall (41) is formed integrally with a surrounding the gelling product wall of the fluid collecting container (4).

15. Fluid collection container for receiving an extracted Köφerflüssigkeit, wherein the fluid collection container (2, 3, 4) has a receiving space (42) for receiving the extracted body fluid and the gelling product according to one of claims 1 to 13, wherein the gelling product in a in use position of Fluid collection container (2, 3, 4) lower portion of the receiving space (42) is arranged.